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Waferless One Stage Segmental Lefort I Maxillary Positioning in Transverse Deficiency

NCT03884699 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-03-21

No results posted yet for this study

Summary

In Maxillary transverse deficiency, is waverless lefort I multiple pieces osteotomy using virtually planned patient specific titanium implants feasible and does it provide accuracy?

This prospective case series study evaluating the postoperative outcomes and accuracy of preoperatively planned positional changes together with virtually designed drilling and fixation guides for the waferless positioning and fixation of the multiple pieces Le Fort I of the maxilla using CAD-CAM designed patient-specific implants.

The purpose of this study is to develop and validate an orthognathic CAD/CAM patient specific implant together with template that can guide both the osteotomy and the repositioning of the maxilla during the correction of transverse maxillary deficiency.

Thus, the traditional model and the additional preparation for CAD/CAM surgical splints including scanning dental casts, and recording and moving virtual dental casts, were not required. The preoperative and laboratory procedures were simplified, and the intermediate splint technique was eliminated, so the associated potential errors were avoided.

Conditions

  • Lefort I Osteotomy

Interventions

PROCEDURE

Accuracy of planned transverse Maxillary distance using Mimics software after fixation using Patient specific implant

Virtual planning: based on clinical evaluation and 3D cephalometric analysis. Virtual osteotomies mimicking segmental Lefort I and a bilateral sagittal split osteotomy. Designing the virtual cutting guide. Virtual movement into the desired positions of the segmented maxilla and mandible, based on: clinical evaluation, 3D cephalometric analysis and the desired occlusion. Once the optimal position of the maxilla is achieved, a patient specific implant will be virtually designed to fix the segmented maxilla in its new position. Fabrication of the cutting guide using additive manufacturing technique from polymer material. Fabrication of PSI from titanium alloy using additive manufacturing technique.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Rasha Taman, Msc · Cairo University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2020-09-30
Completion
2021-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03884699 on ClinicalTrials.gov